Abbott Medical

Complete recall history across all FDA and CPSC categories — 42 total recalls

Abbott Medical appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (42)

FDA medical device enforcement actions by Abbott Medical

Date Product Reason Class
Oct 6, 2025 Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Imp... Class II
Oct 6, 2025 Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Imp... Class II
Feb 15, 2025 Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code... Due to a manufacturing issue, leadless pacemakers may have been exposed to hi... Class II
Nov 21, 2024 The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model ... Due to a programmer software anomaly, during finalizing of the leadless pacem... Class II
Oct 17, 2024 Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NV... A manufacturing error resulting in acceptance of valves with a leaflet deflec... Class II
Oct 17, 2024 Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, N... A manufacturing error resulting in acceptance of valves with a leaflet deflec... Class II
Oct 17, 2024 Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 3... A manufacturing error resulting in acceptance of valves with a leaflet deflec... Class II
Oct 17, 2024 Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile A manufacturing error resulting in acceptance of valves with a leaflet deflec... Class II
Oct 17, 2024 Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile A manufacturing error resulting in acceptance of valves with a leaflet deflec... Class II
Oct 1, 2024 Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merl... Due to heart transmitter not being able to upgrade to the current software ve... Class III
Oct 1, 2024 Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is i... Due to heart transmitter not being able to upgrade to the current software ve... Class III
May 22, 2024 Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicat... Class II
May 22, 2024 Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicat... Class II
May 22, 2024 Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicat... Class II
May 22, 2024 Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicat... Class II
May 16, 2024 Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective r... Class II
May 16, 2024 Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective r... Class II
May 16, 2024 Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective r... Class II
May 16, 2024 Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective r... Class II
May 16, 2024 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective r... Class II
May 16, 2024 Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective r... Class II
May 16, 2024 Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY Deep brain stimulation system will first turn off after approximately 50 days... Class II
May 16, 2024 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective r... Class II
May 16, 2024 Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective r... Class II
May 16, 2024 Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective r... Class II
May 16, 2024 Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective r... Class II
May 16, 2024 Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective r... Class II
May 16, 2024 Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective r... Class II
Feb 5, 2024 Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO Their is a potential that electromagnetic interference may cause leadless pac... Class II
Aug 16, 2023 Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDH... Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibril... Class II
Aug 16, 2023 Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gal... Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibril... Class II
Jul 18, 2023 Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: ... Firm has received complaints from patients who are unable to exit MRI (Magnet... Class I
Jul 18, 2023 Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: Th... Firm has received complaints from patients who are unable to exit MRI (Magnet... Class I
Jul 18, 2023 Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Pro... Firm has received complaints from patients who are unable to exit MRI (Magnet... Class I
Jul 18, 2023 Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The ... Firm has received complaints from patients who are unable to exit MRI (Magnet... Class I
Jul 18, 2023 Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Pro... Firm has received complaints from patients who are unable to exit MRI (Magnet... Class I
Jul 18, 2023 Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: ... Firm has received complaints from patients who are unable to exit MRI (Magnet... Class I
Jul 18, 2023 Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The ... Firm has received complaints from patients who are unable to exit MRI (Magnet... Class I
Dec 9, 2019 Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 40... Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dila... Class II
Dec 9, 2019 Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and... Class II
Nov 11, 2019 CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF... A manufacturing error caused a single lot of 10mm active tip length Cannulas ... Class II
Oct 14, 2019 Radiofrequency Grounding Pad, REF RF-DGP-L Affected lots were manufactured with the protective release liner in an incor... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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